Amgen Inc and Allergan Plc said they have submitted an application to the European health regulator seeking approval of their biosimilar version of Roche Holding AG’s blockbuster cancer treatment, Avastin.
The submission is based on the results of a late-stage study that showed Amgen and Allergan’s ABP 215 was as safety and effective as Avastin in patients with the most common form of lung cancer.
Avastin is also approved for use by patients with cancer of the colon, kidney, ovarian and breast. It generated sales of about $5 billion in the first nine months of this year.
The drug is a biologic, which are manufactured in living cells and then extracted and purified. Since the process is more complex than that used to make traditional drugs, it cannot be copied with precision.